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Bringing the patient voice into clinical trials with clinical outcome assessments

Clarivate

The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. Several years of evidence generation culminated in the FDA approval of the first systemic treatment for alopecia areata. The FDA included Clarivate data from the COA development by in the approved labelling.

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RFID: The future of smart labelling?

Pharmaceutical Technology

Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. Various uses soon became apparent including those for supply chain management, anti-counterfeiting, and to improve patient safety. In recent times, various global administrators have issued regulatory standards.

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How clinical outcome assessments can help us understand the patient experience

Clarivate

The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. These incorporated a variety of methodologies including literature reviews, patient preferences, exit interviews and FDA dossier development. All data were collated in FDA COA Evidence Dossiers.

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Gene therapy: a radical pharmaceutical revolution

European Pharmaceutical Review

Considerable progress has been made in other areas including enhancing safety, improving treatment administration and patient monitoring systems and implementing innovative pricing strategies – all with the goal of providing timely access to eligible patients who can benefit from these treatments. Internet] FDA. Annu Rev Med.

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Learning from lecanemab: a breakthrough treatment

European Pharmaceutical Review

On 6 January, a milestone was achieved—lecanemab gained US Food and Drug Administration (FDA) approval via the Accelerated Approval pathway. In clinical trials, we targeted the early AD population with confirmed amyloid in the brain and found the right optimal dose that balanced efficacy and safety in the large Phase II dose-ranging study.

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Comparison of Humira biosimilars in the US and Europe

Pharmaceutical Technology

Amgen’s (US) Amjevita (adalimumab) is the first Humira biosimilar, launched in February 2023, and seven other FDA-approved biosimilars are expected to arrive on the US market later this year. In addition, two more Humira biosimilars are currently under FDA review and both are anticipated to launch in 2023.

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Drug pricing increases are disgraceful

World of DTC Marketing

In November 2017, a study published in JAMA Internal Medicine examined the costs of developing 10 cancer drugs approved by the FDA from 2006 to 2015 and provided a strong contrast to the Tufts study from a year before. years to win FDA approval, at a median cost of $648 million.

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